Boehringer Ingelheim Pharmaceuticals, Inc. announced the U.S FDA granted accelerated approval to Praxbind (idarucizumab), a specific reversal agent for Pradaxa® (dabigatran etexilate mesylate).  The U.S FDA approved Pradaxa in 2010 to prevent stroke and systemic blood clots in patients with atrial fibrillation, as well as for the treatment and prevention of deep venous thrombosis and pulmonary embolism. Praxbind is an antibody fragment designed to reverse the anticoagulant effects of Pradaxa, which prevents clotting by blocking the enzyme thrombin.  The FDA granted Praxbind Breakthrough Therapy Designation and the application received Priority Review.

The availability of Praxbind now provides a unique option for reversing anticoagulation in patients taking Pradaxa For now, Pradaxa is the only antithrombin treatment with an approved reversal agent.

 

References:

  1. http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm467300.htm
  2. http://us.boehringer-ingelheim.com/news_events/press_releases/press_release_archive/2015/10-16-2015-fda-approves-praxbind-idarucizumab-specific-reversal-agent-pradaxa-dabigatran-etexilate-mesylate.html